Rituximab 375mg/m2 at day 0, Meththylprednisolone 500mg IV at days 1 to 5, Etoposide 40mg/m2 at days 1 to 4, Cisplatin 25mg/m2 at days 1 to 4, Cytarabine 2000mg/m2 at day 5. Frequence of cycles: every 3 weeks. Numbers of cycles: 3 cycles.

Drug: R-ESHAP

Rituximab 375mg/m2 at day 0, Meththylprednisolone 500mg IV at days 1 to 5, Etoposide 40mg/m2 at days 1 to 4, Cisplatin 25mg/m2 at days 1 to 4, Cytarabine 2000mg/m2 at day 5. Frequence of cycles: every 3 weeks. Numbers of cycles: 3 cycles.

Other Name: Mabthera

Detailed Description:

The standard treatment in patients with refractory or relapsed diffuse large B-cell lymphoma is salvage chemotherapy followed by autologous transplantation for responsive patients. However, the standard of salvage chemotherapy remains uncertain. This study is to evaluate the efficacy and safety of R-ESHAP regimen in a multi-center basis.

Eligibility

Ages Eligible for Study:

18 Years to 65 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Age range: 18-65 years old

Histological confirmed diffuse large B-cell lymphoma

Refractory or first relapsed disease

Prior anthracycline exposure

Measurable disease

ECOG performance status 0-1

Life expectancy of more than 3 months

Bone marrow function: ANC≧1.5×109/L, PLT≧100×109/L, Hb≧90g/L

Liver function: total bilirubin, ALT and AST <1.5×UNL

Renal function: Cr<1.5×UNL, CCR≧50ml/min

No contraindication for transplantation

Exclusion Criteria:

Evidence of CNS and bone marrow involvement

More than 1 type of chemotherapy regimens exposure

High level of HBV DNA

Contraindication of high-dose methylprednisolone

Pregnant or lactating women

History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix

History of allergic reaction/hypersensitivity to rituximab

Significant active infection

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01278602